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defibrotide

Trade name: defitelio

Animal productapprovedOrphan Drug FDAFast Track FDA

Approved

Mar 30, 2016

Defibrotide, sold under the brand name Defitelio, is a mixture of single-stranded oligonucleotides that is purified from the intestinal mucosa of pigs. It is used to treat veno-occlusive disease of the liver of people having had a bone marrow transplant, with different limitations in the US and the European Union. It works by protecting the cells lining blood vessels in the liver and preventing blood clotting; the way it does this is not well understood. — Wikipedia

Clinical trial activity

22 trials · 21 clinical orgs · 2 marketing orgs

Phase 1
2
Phase 2
17
Phase 3
4
Phase 4
1

Earliest trial started Apr 1, 2000 (NCT00003966)

Timeline

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. May 21, 2003

    Orphan Drug Designation

  3. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  4. Jan 1, 2006

    Jazz Pharmaceuticals — Earliest Phase 3 Sponsor(trial)

2010s

  1. Mar 30, 2016

    Gentium — Earliest FDA Approval

  2. Mar 30, 2016

    Jazz Pharmaceuticals — NDA Secondary Org

  3. Mar 30, 2016

    Gentium — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackMar 30, 2016

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • defibrinotide
  • defibrinotide
  • defibrotide
  • defibrotide
  • defibrotide
  • defibrotide
  • defibrotide
  • defibrotide
  • defibrotide
  • defibrotide
  • defibrotide (bovine)
  • defibrotide sodium
  • defibrotide sodium
  • defibrotide sodium
  • defibrotide sodium
  • defibrotide sodium
  • defitelio
  • defitelio
  • defitelio
  • jzp381
  • jzp-381
  • jzp-381

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06182410Phase 2Mar 1, 2024Jazz Pharmaceuticals, University of California, San Francisco
NCT05987124Phase 2Dec 1, 2023New York Medical College
NCT04777422Phase 2Feb 24, 2021Columbia University, Johns Hopkins University, New York Medical College, New York University
NCT04652115Phase 2Jan 1, 2021Harvard University, Jazz Pharmaceuticals
NCT04530604Phase 1Oct 1, 2020Jazz Pharmaceuticals, University of Michigan
NCT04313036Phase 2May 1, 2020Loyola University
NCT04348383Phase 2Apr 8, 2020Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
NCT04335201Phase 2Apr 6, 2020Vita-Salute University of Milano. Italy
NCT03954106Phase 2Aug 31, 2019Jazz Pharmaceuticals
NCT03384693Phase 2May 1, 2018University of California, San Francisco
NCT03339297Phase 2Feb 21, 2018Jazz Pharmaceuticals
NCT03805581Phase 2Jan 12, 2018Johns Hopkins University, New York Medical College
NCT02675959Phase 2May 1, 2017New York Medical College
NCT02876601Phase 4Apr 1, 2017Medical University of Vienna, University of Vienna
NCT02851407Phase 3Sep 1, 2016Jazz Pharmaceuticals
NCT00628498Phase 3Dec 1, 2007Harvard University, Jazz Pharmaceuticals
NCT00358501Phase 3Jul 1, 2006Food and Drug Administration, Harvard University, Jazz Pharmaceuticals
NCT00406978Phase 1/Phase 2 (Phase 2)Feb 1, 2006University of Turin
NCT00272948Phase 2/Phase 3 (Phase 3)Dec 1, 2005Deutsche Krebshilfe e.V., European Group for Blood and Marrow Transplantation, Jazz Pharmaceuticals, University of Ulm
NCT00263978N/ANov 1, 2005Emory University
Showing 20 of 22 trials
Page 1 / 2

Organizations

Research & Development (21)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Jazz PharmaceuticalsFor profit10532000
Harvard UniversityAcademic/Hospital4222000
New York Medical CollegeAcademic/Hospital4412017
Johns Hopkins UniversityAcademic/Hospital2012018
University of California, San FranciscoAcademic/Hospital2212018
Columbia UniversityAcademic/Hospital1012021
Deutsche Krebshilfe e.V.Academic/Hospital1012005
Emory UniversityAcademic/Hospital1112005
European Group for Blood and Marrow TransplantationAcademic/Hospital1112005
Food and Drug AdministrationGovernment1012006
Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaAcademic/Hospital1112020
Loyola UniversityAcademic/Hospital1112020
Medical University of ViennaAcademic/Hospital1112017
National Cancer Institute (NCI)Government1012000
New York UniversityAcademic/Hospital1012021
St. Jude Children's HospitalAcademic/Hospital1112003
University of MichiganAcademic/Hospital1112020
University of TurinAcademic/Hospital1112006
University of UlmAcademic/Hospital1012005
University of ViennaAcademic/Hospital1012017
21 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
GentiumFor profitNDAMar 30, 2016
Jazz PharmaceuticalsFor profitNDA2Mar 30, 2016